Design Quality Engineer

Execute DHF and QMS migration activities. Ensure design documentation, risk files, V&V reports meet regulatory and QMS standards. Review & approve design control documents with complete traceability. Support DHF remediation and document consolidation. Collaborate with R&D, Regulatory, Manufacturing & Quality teams for smooth design transfer. Identify and close gaps per ISO 13485, FDA 21 CFR 820 & EU MDR requirements. Support audit preparation and inspection readiness. Participate in change control and assess regulatory/quality impact. Ensure alignment with internal quality systems and regulatory expectations.